RecallDepth

Clinician Programmer Application (CPA) model A610 Clinician Software Application

This recall is currently active, issued September 23, 2021. It was issued by Medtronic Neuromodulation.

Company
Medtronic Neuromodulation
Recall Initiated
September 23, 2021
Recall Number
Z-0201-2022
Quantity
3302
Firm Location
Minneapolis, MN
Official Source
View on FDA website ↗

Reason for Recall

A software anomaly may occur with the clinician programmer application.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.

Lot / Code Info

Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081

Root Cause

Software design

Action Taken

A customer letter was distributed to impacted customers beginning September 16, 2021. Customers are asked to contact their Medtronic representative or Medtronic Technical Services at 1-800-707-0933 to troubleshoot should they experience the software anomaly issue.

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